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Injectable Receives FDA Approval

May 2016

Juvéderm Volbella XC (Allergan) received FDA approval for use in the lips for lip augmentation and for correction of perioral rhytids, or perioral lines, in adults over the age of 21. In clinical trials, injectable was found to effectively increase lip fullness and soften the appearance of lines around the mouth in a majority of subjects through 1 year. It will be available to patients in October 2016.

“Many of my patients are very bothered by the lines that can appear around the lips, known as perioral rhytids. Additionally, when seeking lip augmentation, patients want a smooth, result that is not drastic,” said Dr David E. Bank, clinical trial investigator and founder of The Center for Dermatology, Cosmetic & Laser Surgery. "Juvéderm Volbella XC adds fullness to the lips and softens the appearance of the lines around the lips. With it I am able to subtly enhance my patients' pout."

The safety and effectiveness of the injectable has been demonstrated in several clinical trials including the US pivotal study where 168 subjects were treated with Juvéderm Volbella XC.  A 5-point scale was used to evaluate the effectiveness of the product for lip fullness and a 4-point scale to evaluate the effectiveness of the product for smoothing lines around the mouth. Approximately two-thirds of subjects treated with it showed improvement in lip fullness and perioral lines through 1 year. The safety of the injectable was observed to be similar to that of the control. The most common side effects were temporary responses at the treatment site such as swelling, tenderness, bruising, firmness lumps/bumps, rednesss, pain, discoloration, and itching. Most of these side effects resolved within 30 days. 

Juvéderm Volbella XC (Allergan) received FDA approval for use in the lips for lip augmentation and for correction of perioral rhytids, or perioral lines, in adults over the age of 21. In clinical trials, injectable was found to effectively increase lip fullness and soften the appearance of lines around the mouth in a majority of subjects through 1 year. It will be available to patients in October 2016.

“Many of my patients are very bothered by the lines that can appear around the lips, known as perioral rhytids. Additionally, when seeking lip augmentation, patients want a smooth, result that is not drastic,” said Dr David E. Bank, clinical trial investigator and founder of The Center for Dermatology, Cosmetic & Laser Surgery. "Juvéderm Volbella XC adds fullness to the lips and softens the appearance of the lines around the lips. With it I am able to subtly enhance my patients' pout."

The safety and effectiveness of the injectable has been demonstrated in several clinical trials including the US pivotal study where 168 subjects were treated with Juvéderm Volbella XC.  A 5-point scale was used to evaluate the effectiveness of the product for lip fullness and a 4-point scale to evaluate the effectiveness of the product for smoothing lines around the mouth. Approximately two-thirds of subjects treated with it showed improvement in lip fullness and perioral lines through 1 year. The safety of the injectable was observed to be similar to that of the control. The most common side effects were temporary responses at the treatment site such as swelling, tenderness, bruising, firmness lumps/bumps, rednesss, pain, discoloration, and itching. Most of these side effects resolved within 30 days. 

Juvéderm Volbella XC (Allergan) received FDA approval for use in the lips for lip augmentation and for correction of perioral rhytids, or perioral lines, in adults over the age of 21. In clinical trials, injectable was found to effectively increase lip fullness and soften the appearance of lines around the mouth in a majority of subjects through 1 year. It will be available to patients in October 2016.

“Many of my patients are very bothered by the lines that can appear around the lips, known as perioral rhytids. Additionally, when seeking lip augmentation, patients want a smooth, result that is not drastic,” said Dr David E. Bank, clinical trial investigator and founder of The Center for Dermatology, Cosmetic & Laser Surgery. "Juvéderm Volbella XC adds fullness to the lips and softens the appearance of the lines around the lips. With it I am able to subtly enhance my patients' pout."

The safety and effectiveness of the injectable has been demonstrated in several clinical trials including the US pivotal study where 168 subjects were treated with Juvéderm Volbella XC.  A 5-point scale was used to evaluate the effectiveness of the product for lip fullness and a 4-point scale to evaluate the effectiveness of the product for smoothing lines around the mouth. Approximately two-thirds of subjects treated with it showed improvement in lip fullness and perioral lines through 1 year. The safety of the injectable was observed to be similar to that of the control. The most common side effects were temporary responses at the treatment site such as swelling, tenderness, bruising, firmness lumps/bumps, rednesss, pain, discoloration, and itching. Most of these side effects resolved within 30 days. 

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